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United States · US · US:72888-123_473ce2a5-25a3-811b-e063-6294a90a0456
Guanfacine
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1172888123001000 TABLET in 1 BOTTLE (72888-123-00)
- ndc117288812301100 TABLET in 1 BOTTLE (72888-123-01)
- ndc117288812305500 TABLET in 1 BOTTLE (72888-123-05)
- ndc11728881233030 TABLET in 1 BOTTLE (72888-123-30)
Annotations
UNII (FDA Substance ID)
PML56A160O
GUANFACINE HYDROCHLORIDE
RxCUI 203142
Orange Book
A216762
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Guanfacine Hydrochloride Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "PML56A160O",
"rxcui": "203142",
"inchikey": "DGFYECXYGUIODH-UHFFFAOYSA-N",
"display_name": "GUANFACINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6006df06-0448-462d-b81e-7add50a6d71b": {
"match": "brand_token",
"title": "GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "12",
"published_date": "2026-06-01"
}
},
"productid": "72888-123_473ce2a5-25a3-811b-e063-6294a90a0456",
"productndc": "72888-123",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216762",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Oct 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Oct 17, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GUANFACINE HYDROCHLORIDE",
"shortage_reason": "Guanfacine Hydrochloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Guanfacine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216762",
"marketing_category": "ANDA",
"nonproprietary_name": "Guanfacine",
"start_marketing_date": "20211001",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C02AC02.
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